1. Managing Conflicts of Interest at the IRB and Institutional Level: INSTITUTIONAL CONFLICTS OF INTEREST Claudia R. Adkison, J.D., Ph.D. Executive Associate Dean Administration and Faculty Affairs Emory University School of Medicine PRIM&R Meeting, Boston, MA May 3-5, 2004

2. TO MAINTAIN THE PUBLIC TRUST... Institutional officials must Make decisions and policies for the institution that are free from improper bias or conflict of interest Be able to document that they have done so

3. COMPETING INTERESTS The institution has interests in Its financial gain from external entities – donors, research sponsors, companies, Board and Officer investments Its own academic and clinical missions and the policies that support them – allocations of space, money, people; review and approval processes; monitoring, auditing, compliance, and discipline Its reputation Its research integrity The safety and welfare of its human subjects

4. INSTITUTIONAL CONFLICT OF INTEREST (ICOI) When the financial interests of the institution, or of an institutional official acting in his/her official capacity, or of IRB members, might affect or appear to affect Any phase of its research mission -- conduct, review, oversight and compliance, outcome Finances and economic status of the institution Missions of the institution Appropriate vendor relationships Employment practices

5. POTENTIAL ICOI (RESEARCH) When the institution (or institutional officials who manage or oversee research or IRB members): Might get royalties from the sale of the product that is to be investigated Holds any equity through licensing its technology to a non-publicly traded research sponsor (e.g., startup company) Holds ownership interests >$100K through licensing its technology to a publicly-traded research sponsor Gets a significant gift from a potential research sponsor

6. POTENTIAL ICOI (RESEARCH) (2) When an institutional official who has research responsibility has a Significant financial interest in the research sponsor or the product to be investigated –Equity interest –Consulting relationship –Honoraria, gifts –Service as officer, board member Purchasing relationship with the research sponsor (vendor)

7. RULES AND REGULATIONS ON ICOI Various regulations and statutes govern ICOI in finance, employment, Board duties, etc. (IRS, SEC, corporate law... ) No federal regulations on ICOI in research Excellent guidance for institutions engaged in human subject research, adaptable to broader application: –Protecting Subjects, Preserving Trust, Promoting Progress II: Principles & Recommendations for Oversight of an Institution’s Financial Interests in Human Subjects Research AAMC Task Force on Financial Conflicts of Interest in Clinical Research, October 2002

8. HYPOTHETICAL CASE 1: Department Chair Chair of the Department of Pathology has a startup company that proposes to sponsor the research of Dr. Doe, Asst Professor of Pathology Chair’s authority raises this to an ICOI –Issues with internal as well as external perceptions Some options (consider basic science v. clinical research) –Prohibit the sponsorship –Transfer oversight of Dr. Doe to another Dept Chair for evaluation, salary, promotion, space, resources considerations, research oversight

9. HYPOTHETICAL CASE 2: Department Chair Department Chair has an extensive consulting relationship with a company that proposes to sponsor the Chair’s research – personal COI. Chair assigns the project to Asst Prof Doe as PI but will remain involved Arguably an ICOI, since the authority of Chair could influence the outcome –Plan: Remove the Chair from the project; require an unbiased expert to review the manuscript and data –Argument: Young professors benefit from the Chair’s advice and mentoring Basic v. clinical considerations in management

10. HYPOTHETICAL CASE 3: EVP, DEAN, COO EVP/Dean/COO invests $50K to take institutional equity in Dr. Path’s startup company to develop vaccines (in good but short-sighted faith!) Suggestion: Limit financial oversight and investment to Board, institutional CFO (per AAMC advice) –But medical EVPs and Deans may not want to turn over their discretionary accounts to Board and CFO for management and investment –Blanket rules do not fit every institution

11. HYPOTHETICAL CASE 3: EVP, DEAN, COO (2) Suggested options –Establish an external holding company to manage institutional equity holdings –Have an institutional committee outside the control of the EVP/Dean/COO make or review all further decisions related to the investment –Prohibit such investments entirely Investment was a short-sighted decision because...

12. HYPOTHETICAL CASE 4: Tech Transfer Officer and Boss Dr. Path asks institution to license the vaccine technology that he generated to his company –ICOI because institution has equity in company, would receive royalties –ICOI because Dr. Path is a conflicted institutional officer Institution has duty to ensure that the technology is transferred in the way that is most likely to benefit the public Plan: Have the technology independently evaluated for value and for other markets By whom? Who pays?

13. HYPOTHETICAL CASE 5: EVP, DEAN, COO Institution licenses its vaccine technology to Prof. Doe’s company, in which the institution holds equity. Institution will receive royalties from the sale of the vaccine Company proposes to sponsor clinical research at institution to test the vaccine Options –Set up a management plan for disclosures, research and data oversight, and oversight of patient involvement that puts EVP, DEAN, COO at arm’s length AND –Have an external review board monitor the management plan

14. HYPOTHETICAL CASE 6: SERVICE CHIEF Dr. Smith routinely recommends the surgical sutures, stents, and other devices purchased by the hospital. Dr. Smith is compensated >$10K as a consultant for the suture company, as a speaker for the stent company, and holds >$20K stock in the device company. –ICOI with the institutional vendor policy –Prior disclosure by all who influence purchasing

15. A FEW SIMPLE RULES A FEW SIMPLE RULES Separate the roles of administrators who oversee and make institutional decisions about research from those who oversee investments and technology transfer Have established policies and procedures for the identification, disclosure, review, and management or elimination of potential ICOI Have an ICOI Committee with some external members, high-ranking independent internal members (not COI Committee) Make use of external committees, ad hoc or standing, routinely or in certain cases, if feasible

16. A FEW SIMPLE RULES (2) A FEW SIMPLE RULES (2) Have good communication among the ICOI Committee, COI Committee(s), Tech Transfer Office, and IRB Disclose, disclose, disclose Require IRB members to disclose potential conflicts of interest and recuse or divest if appropriate